Geron discontinues late-stage trial of blood cancer drug, shares plunge

Oct 28 — Geron said on Wednesday it would halt a late-stage ​trial of its blood cancer treatment, marking a setback for the company's only commercial product, sending its shares plunging ‌20% in early trading.

The drug, branded as Rytelo, was being evaluated as a treatment for ⁠myelofibrosis, a rare type of ​blood cancer in which scar ⁠tissue gradually builds up in the bone marrow.

Geron said it ‌made the decision following ‌an independent data monitoring committee's recommendation that the trial, ⁠named IMpactMF, was unlikely to achieve ⁠its main goal of overall survival, compared with the best available therapy.

Rytelo received US approval in 2024 for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS), a group of blood cancers.

The trial was disappointing, but no new safety concerns were ‌seen despite higher and more frequent ​dosing than in LR-MDS, supporting confidence in the ongoing Rytelo launch, said TD Cowen analyst Tara Bancroft.

Geron said a detailed analysis of the data would be conducted, and study findings would be shared at a future date.

The trial enrolled 327 patients with high-risk myelofibrosis whose disease had returned or failed to respond ​after treatment with a JAK inhibitor, a type of drug used ‌to manage symptoms ‌and reduce ⁠spleen enlargement.

"We do not believe this outcome meaningfully alters physician perception of Rytelo in LR-MDS as the compound's approved indication and the anchor of the commercial story," said Wedbush analyst Robert Driscoll.

Rytelo competes ‌with Bristol Myers Squibb's ​Reblozyl. It generated $57.5 million in second-quarter ‌revenue, and the company ⁠expects full-year ​sales of $220 million to $240 million.

(Reporting by Christy Santhosh in Bengaluru; Editing by ​Maju Samuel)

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